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Recall Observatory FDA recall evidence

Device product

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Z-1391-2022

November 12, 2019

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 90484
Status
Completed
Classification
Class II
Quantity
67
Official record key
device-enforcement:Z-1391-2022

Official wording

Reason: Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

Code information: UDI-DI (GTIN): 04046963419639

Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.